The approval was granted on the basis of the results of a domestic phase II clinical trial and overseas phase III clinical trials.
The results from the overseas Phase III clinical trials in advanced or recurrent breast cancer patients previously untreated with chemotherapy, those who received Avastin in conjunction with paclitaxel, demonstrated prolongation of progression-free survival compared to those who received paclitaxel alone.
In addition, the Phase II clinical trial confirmed the efficacy in Japanese patients, and also confirmed that the tolerability of Avastin combined with paclitaxel in Japanese patients were comparable to those seen in overseas clinical trials.